Page 55 - Getting Started

11. Ineffective root cause analysis. Finding the
root cause of a problem is sometimes difficult
to accomplish, but it is an important step to
permanently solving a problem. Many
methods and tools, such as 5-Why, 8D,
Fishbone, etc., are available to help companies
identify root causes so the problem can be
addressed and a solution can be implemented.
Pick the method that works best for you and
use it throughout your organization. If there are
multiple variables it may take more than one
round of root cause investigations and
preventive actions to resolve the issue.

12. Incomplete or no verification activities
defined. Verification is simply stated as “Are we
doing what we say we are doing?” Verification,
at minimum, should include record review and
observation of monitoring activity.

13. No validation. Validation is simply stated as
“Is our program effective in controlling the
identified hazards?” Initially, make sure you
validate there is scientific proof that your
control measures and critical limits will be
effective. Revalidate your program annually to
ensure hazards are controlled.

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